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510(k) K202478

Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares by Boston Scientific Corporation — Product Code FDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2020
Date Received
August 28, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Snare, Flexible
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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Other clearances for product code FDI

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  • K220846 — CORE-SNARE (November 21, 2022)
  • K220089 — Disposable Polyp Snare (September 22, 2022)
  • K220790 — Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare (June 27, 2022)
  • K213222 — Disposable Polypectomy Snare (June 6, 2022)
  • K212860 — SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB- (October 7, 2021)
  • K200745 — Lariat, Hot/Cold Snare (April 21, 2020)
  • K190512 — SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare (November 22, 2019)
  • K191048 — AcuSnare Polypectomy Snare - Duckbill (July 18, 2019)